A meta-analysis of 137 clinical trials finds triptan drugs are among the most effective for treating migraines, while newer ditan and gepant drugs were rated less highly

Dopamine was long thought to play a part in the placebo effect for pain relief, but a new study is questioning its true role

A flurry of studies has found microplastics in nearly every organ in the human body, from the brain to the testicles. But very few have revealed whether these tiny bits of plastic impact our health

The latest research on caffeine reveals why coffee and decaf can be so good for your health, but energy drinks can be lethal

People who listen to music after having surgery report lower levels of pain and require less morphine than those who don't

Zapping the skin with electricity could stop bacteria that live there harmlessly from entering the body and causing blood poisoning

From seed oils to olive oil, we now have an overwhelming choice of what to cook with. Here’s how they all stack up, according to the scientific evidence

Montana public health officials are investigating an outbreak of infections caused by Salmonella. The Cascade City-County Health Department in Great Falls is reporting that six students at Sacajawea and Valley View elementary schools have tested positive for the pathogen. A staff member at another school has also tested positive. There... Continue Reading

From the busy cities to ocean waters, our need to illuminate the world has had some strange and tragic consequences

Designing a sensory-friendly bedroom for a child with autism is essential in creating a calming and functional environment that caters to their unique sensory needs. Sensory processing challenges are common among children with autism, meaning that their surroundings can either help regulate their emotions or lead to sensory overload. While companies like Interactive 365 provide […]

The post How To Set Up The Perfect Sensory Bedroom For Kids With Autism appeared first on Chart Attack.

Last year, FDA advisers unanimously voted that oral phenylephrine is ineffective.

Threat actor exploited account credentials swept up by infostealers years earlier.

1. Study reveals how 3D environments affect bacterial growth and survival  The Hindu
2. 3D environments influence bacterial growth & survival  The Times of India
3. Shape Matters: New Research Reveals Impact of 3D Environments on Bacterial Growth  Research Matters
4. Study reveals role of 3D environments in influencing bacterial survival and growth  Bangalore Mirror

The pedigree of the producers and writers involved is cause for concern, though.

Bob Singleton revealed he was threatened with ‘death and dismemberment’ as music director for ‘Barney & Friends’

IF you buy a large cappuccino you may find it is quite cold by the time you get to the bottom. Thankfully, there is now a solution to this.

Une découverte biochimique intrigante pourrait permettre d’identifier rapidement les patients à haut risque.

No, but the direction of our hair whorls could teach us about human development

Today’s guest post comes from George Moore, Chief Information Technology Officer at CareMetx.

As George explains using novel survey data, manufacturers view new technologies  as crucial for patient services. He then explains how digital technology, artificial intelligence (AI), and machine learning (ML) can be used to improve patient adherence and increase hub efficiencies.

To learn more, download CareMetx’s new 2024 Patient Services Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Read on for George’s insights.
Read more »

Today’s guest post comes from Chris Dowd, Senior VP of Market Development at ConnectiveRx.

Chris examines three key trends that will affect patient support programs: the Inflation Reduction Act (IRA), legal/regulatory battles over copay adjustment programs, and uncertainties following a national election. He then outlines three actions that should guide manufacturers' preparation.

To learn more, register for ConnectiveRx’s free webinar on December 11: The Perfect Storm? Patient Support Programming in 2025 and Beyond.

Read on for Chris’s insights.
Read more »

Agencies with healthcare clients in pharmaceuticals, healthcare services, digital health apps, or health-related connected devices such as wearables should take note that the Federal Trade Commission (FTC) final rule updating its Health Breach Notification Rule (HBNR) that took effect on July 29, 2024. The FTC considers a breach to include a covered entity’s unauthorized disclosure […]

The type 2 diabetes mellitus drug semaglutide is effective for weight loss in non-diabetic overweight or obese adults, when taken alongside a reduced-calorie diet and exercise, researchers have found.

It is a surprisingly common peril among analysts: we don’t have the data to answer the question we’re interested in, so we answer a related question where we do have data. Unfortunately, the new answer turns out to shed no light on the original interesting question.

This is sometimes referred to as the Streetlight Effect – a phenomenon aptly illustrated by Mutt and Jeff over half a century ago:

This is the situation that the Tufts Center for the Study of Drug Development seems to have gotten itself into in its latest "Impact Report".  It’s worth walking through the process of how an interesting question ends up in an uninteresting answer.

So, here’s an interesting question:

My company owns a drug that may be approvable through FDA’s 505(b)(2) pathway. What is the estimated time and cost difference between pursuing 505(b)(2) approval and conventional approval?

That’s "interesting", I suppose I should add, for a certain subset of folks working in drug development and commercialization. It’s only interesting to that peculiar niche, but for those people I suspect it’s extremely interesting - because it is a real situation that a drug company may find itself in, and there are concrete consequences to the decision.

Unfortunately, this is also a really difficult question to answer. As phrased, you'd almost need a randomized trial to answer it. Let’s create a version which is less interesting but easier to answer:

What are the overall development time and cost differences between drugs seeking approval via 505(b)(2) and conventional pathways?

This is much easier to answer, as pharmaceutical companies could look back on development times and costs of all their compounds, and directly compare the different types. It is, however, a much less useful question. Many new drugs are simply not eligible for 505(b)(2) approval. If those drugs

Extreme qualitative differences of 505(b)(2) drugs. Source: Thomson Reuters analysis via RAPS

are substantially different in any way (riskier, more novel, etc.), then they will change the comparison in highly non-useful ways. In fact, in 2014, only 1 drug classified as a New Molecular Entity (NME) went through 505(b)(2) approval, versus 32 that went through conventional approval. And in fact, there are many qualities that set 505(b)(2) drugs apart.

So we’re likely to get a lot of confounding factors in our comparison, and it’s unclear how the answer would (or should) guide us if we were truly trying to decide which route to take for a particular new drug. It might help us if we were trying to evaluate a large-scale shift to prioritizing 505(b)(2) eligible drugs, however.

Unfortunately, even this question is apparently too difficult to answer. Instead, the Tufts CSDD chose to ask and answer yet another variant:

What is the difference in time that it takes the FDA for its internal review process between 505(b)(2) and conventionally-approved drugs?

This question has the supreme virtue of being answerable. In fact, I believe that all of the data you’d need is contained within the approval letter that FDA posts publishes for each new approved drug.

But at the same time, it isn’t a particularly interesting question anymore. The promise of the 505(b)(2) pathway is that it should reduce total development time and cost, but on both those dimensions, the report appears to fall flat.

• Cost: This analysis says nothing about reduced costs – those savings would mostly come in the form of fewer clinical trials, and this focuses entirely on the FDA review process.
• Time: FDA review and approval is only a fraction of a drug’s journey from patent to market. In fact, it often takes up less than 10% of the time from initial IND to approval. So any differences in approval times will likely easily be overshadowed by differences in time spent in development. 

But even more fundamentally, the problem here is that this study gives the appearance of providing an answer to our original question, but in fact is entirely uninformative in this regard. The accompanying press release states:

The 505(b)(2) approval pathway for new drug applications in the United States, aimed at avoiding unnecessary duplication of studies performed on a previously approved drug, has not led to shorter approval times.

This is more than a bit misleading. The 505(b)(2) statute does not in any way address approval timelines – that’s not it’s intent. So showing that it hasn’t led to shorter approval times is less of an insight than it is a natural consequence of the law as written.

Most importantly, showing that 505(b)(2) drugs had a longer average approval time than conventionally-approved drugs in no way should be interpreted as adding any evidence to the idea that those drugs were slowed down by the 505(b)(2) process itself. Because 505(b)(2) drugs are qualitatively different from other new molecules, this study can’t claim that they would have been developed faster had their owners initially chosen to go the route of conventional approval. In fact, such a decision might have resulted in both increased time in trials and increased approval time.

This study simply is not designed to provide an answer to the truly interesting underlying question.

[Disclosure: the above review is based entirely on a CSDD press release and summary page. The actual report costs $125, which is well in excess of this blog’s expense limit. It is entirely possible that the report itself contains more-informative insights, and I’ll happily update that post if that should come to my attention.]

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters.

The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

This SAS Usage Note illustrates fitting a model containing a spline effect in PROC GLIMMIX. It discusses the spline basis output, the interpretation of the output, how to use the spline model to make predictions, and how to use the LSMEANS and ESTIMATE statements to compute quantities of interest.

Aug 8, 2023

When states use moral language in a dispute, they reduce the possibility of compromise. The possibility of military escalation, meanwhile, rises in response to moral language when states’ domestic audiences accuse their governments of hypocrisy for their willingness to compromise. The Falkland Islands/Islas Malvinas case explores the theory.

Jun 26, 2024

Air-source heat pump adoption will increase heating costs for approximately half of all Massachusetts households due to high electricity prices, according to a new town-level spatial analysis by researchers at Harvard University. Concerns around increased energy bills could challenge Massachusetts’ ability to achieve its ambitions for decarbonization of buildings across the state.

Jun 26, 2024

The first-ever town-level spatial analysis of the effect of heat pump adoption on residential heating bills finds that air-source heat pump adoption will increase heating costs for approximately half of all Massachusetts households due to high electricity prices, challenging the state’s ability to achieve its recently announced ambitions for heat pump adoption.

New KitchenAid�Glass Tea Kettle

Build your career � the MYRA way

Garlock Bankruptcy Overview Video

Gaining Independence While Living with Diabetes

Help Kids Defeat the Mouth Monsters

As Republican presidential candidate Donald Trump stirs up false claims of voter fraud ahead of Election Day, we look at the role of an increasingly “partisan” Federal Election Commission with former FEC general counsel Larry Noble, who explains why “voters of a lot of wealth have the ability to influence elections the way that the rest of us don’t.” As the influence of money in politics grows unchecked, he warns, it has the effect of “silencing the voter.” Noble also responds to multibillionaire Trump supporter Elon Musk’s $1 million giveaways to Pennsylvania voters and discusses the lasting impact of the Supreme Court’s 2010 Citizens United decision on campaign finance law.

Read The Customer Used “Call Corporate”: It Was Not Very Effective

Customer: "Well if you're not going to be doing [possibly illegal thing] for me then I suppose I will just need to call your Corporate office!"
Me: *Not skipping a beat.* "Well, actually I think you’d be better off contacting Jane Lastname at the regional office; here’s her card."

Read The Customer Used “Call Corporate”: It Was Not Very Effective

The Army, The Navy “BBIDGI” The Army, The Navy are a folk duo with the same basic set up as Simon & Garfunkel – two singers, one guitar. The interesting thing with them, most especially on “BBIDGI,” is how their melodies and vocal harmonies are much closer in style and tone to mid 90s through […]

Zapping the skin with electricity could stop bacteria that live there harmlessly from entering the body and causing blood poisoning

Estimates of the number of farms affected range from 100 to 70,000.

Tom Daley's success lures some of the UK's most promising young divers to relocate to his Plymouth training base.

Unless a dengue vaccine protects against all four different virus types, or serotypes, developing a viable vaccine against dengue virus is difficult. The